ISIS-DME: a prospective, randomized, dose-escalation intravitreal steroid injection study for refractory diabetic macular edema.

Abstract

PURPOSE:

: To determine safety and efficacy of intravitreal triamcinolone acetonide (IVTA) for refractory clinically significant diabetic macular edema (DME).

DESIGN:

: Prospective, randomized, dose-escalation pilot study comparing single injection of 2 mg versus 4 mg doses of IVTA.

METHODS:

: Inclusion criteria included clinically significant DME persisting >/=3 months after maximal laser treatment and visual acuity </=20/40. Best-corrected ETDRS vision, intraocular pressure, presence of DME, and fluorescein angiography (FA) were evaluated at 3 months and 6 months after injection.

RESULTS:

: Mean change in visual acuity at 3 months compared to baseline was 7.1 letters (P = 0.01) in the 2 mg group and 12.5 letters in the 4 mg group (P < 0.0001). However, there was not a significant difference in visual improvement between the 2 mg and 4 mg dose groups (P = 0.11). Vision improved >15 letters at 3 months in 23% (3/13) of 2 mg group and in 33% (5/15) of 4 mg group (P = 0.69), and 0% (0/11) and 21% (3/14) at 6 months, respectively (P = 0.23). Visual improvement was more likely in cystoid-type DME than diffuse DME. Intraocular pressure rise of >/=10 mmHg occurred in 19% (3/16) of 2 mg group and 41% (7/17) of 4 mg group.

CONCLUSIONS:

: Both doses of IVTA were well tolerated and had significant positive effects on refractory DME for short term. There were consistent trends throughout the study that suggest that a 4 mg IVTA may be more effective than a 2 mg dose. The benefit of IVTA was greater for cystoid-type DME.

• Authors: Judy E Kim, John S Pollack, David G Miller, Robert A Mittra, Richard F Spaide, Isis Study Group
• Journal: Retina (Philadelphia, Pa.) (Retina) Vol. 28 Issue 5 Pg. 735-40 (May 2008) ISSN: 0275-004X [Print] United States
• PMID: 18463518 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Glucocorticoids
• Triamcinolone Acetonide

Topics

• Adult
• Aged
• Aged, 80 and over
• Diabetic Retinopathy (drug therapy)
• Female
• Fluorescein Angiography
• Glucocorticoids (administration & dosage)
• Humans
• Injections
• Intraocular Pressure (drug effects)
• Macular Edema (drug therapy)
• Male
• Middle Aged
• Pilot Projects
• Prospective Studies
• Single-Blind Method
• Treatment Outcome
• Triamcinolone Acetonide (administration & dosage)
• Visual Acuity (drug effects)
• Vitreous Body